Charged with the responsibility for validation, you will be confronted with a plethora of standards, guidelines, terms and techniques. Understanding the language and the various validation methodologies (along with when and where to use them), is essential for success in this rapidly changing environment.

There are many different paths you can take to achieve a validated state. Sometimes you get there by good luck, sometimes you make a few wrong turns. This training course looks at the tools you need to navigate the various validation pathways you can take to make sure you get it right first time.

Validation-Associate-Checking-GMP-Equipment-and-Process-Against-Validation-Protocol

Content

You will learn about successful validation through:

  • Validation planning
  • Product validation life cycle
  • Protocol and report writing
  • Validation execution
  • Statistics that prove validation
  • And maintaining the validated state

If you're interested in cleaning validation (not addressed in this course), please consider our dedicated cleaning validation course.

Participants

This course has been designed for validation professionals as well as those involved in approving validation plans and projects. It also applies to anyone interested in GMP and the latest trends and methodologies in validation that are rapidly becoming industry standards.

Format and Course Length

The course will be delivered as an online virtual-classroom training session.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training will be delivered as 2 full day sessions, with breaks.

A digital credential (badge) will be issued via Credly on e-mail to recognise successful training completion.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.

Sessions

Each participant will attend both full-day sessions:

 Sessions  Dates  Times
 Day 1  17th May 2022  9:00am-5:00pm
 Day 2  18th May 2022  9:00am-5:00pm

Times are based on Melbourne, Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00

Fee and Discount
  • AUD $1,300 (exc. GST) per participant
    • A 10% discount applies for 3 or more participants from the same company

New Session Dates To Be Advised

Contact us to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions

Jacqueline Berry Circle Gradient Grey BG 300x300

Proposed Trainer

Jacqueline Berry

Jacqueline has over 20 years of experience in the Pharmaceutical industry with specific experience in Quality Management Systems development and maintenance. In that time, Jacqueline has conducted numerous GxP/Quality Audits; conducted gap assessments and delivered training programs to organisations around Australia. In her current role at SeerPharma, Jacqueline leads the lecturing effort of SeerPharma’s Postgraduate GMP Program at the University of Technology Sydney and is actively involved in the development and delivery of this program.